NCT06271603

Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas

Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas (ECOBASO)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 704 (estimated)
• Sponsor: Damae Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.

Detailed description

Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \"equivocal\" lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for \"optical\" biopsies, which appear as an attractive alternative to traditional biopsies. The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.

Conditions

• Basal Cell Carcinoma of the Skin

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	diagnosis based on deepLive™ LC-OCT device	Management of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT technology.
DIAGNOSTIC_TEST	diagnosis based on skin biopsy	Control Arm: Standard management with an initial diagnosis based on skin biopsy

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-02-22
• Last updated: 2024-02-22

Locations

1 site across 1 country: France